ResMed

ResMed

Manufacturing Engineer (2nd Shift)

Calabasas, CA, United States

Sponsorship not specified$79k-$119kDetected 27 days ago
Data AnalysisComplianceProject ManagementProcess ImprovementProcurementSolidWorksMechanical DesignFDA RegulatoryMedical DevicesResearchLeadershipCommunicationCollaborationProblem Solving

About the role

  • Equal Opportunity Employer: ResMed is an equal opportunity employer.
  • We celebrate diversity and are committed to creating an inclusive environment for all employees.

Responsibilities

  • Validate robust manufacturing processes for LSR molding.
  • Drive revalidation activities for process/tool/equipment changes in production
  • Lead process improvement initiatives to enhance productivity, cycle time, and material utilization.
  • Design experiments and analyze data to optimize process parameters, ensuring consistent product quality.
  • Develop and implement control plans, process flow diagrams, and PFMEAs to mitigate risks.
  • Develop and maintain detailed documentation, including work instructions, validation protocols (IQ, OQ, PQ), and standard operating procedures (SOPs).
  • Partner with Quality, Manufacturing Engineering, and Production teams to resolve process challenges.
  • Work with Design Engineering to provide feedback on part designs for manufacturability (DFM).
  • Where a culture driven by excellence helps you not only meet your goals, but also create new ones.

Requirements

  • Bachelor's degree in mechanical engineering, Plastics Engineering, Manufacturing Engineering, or a related field.
  • Minimum 3+ years of experience in Manufacturing Engineering (Ideally with Injection Molding/LSR Manufacturing).
  • Experience supporting production lines in 24X7 environments.
  • Hands-on experience with Molding machines and robotic automation
  • Proven track record in leading and supporting engineering projects in highly collaborative environments
  • Strong knowledge of quality systems (ISO 13485, FDA regulations) and validation protocols.

Nice to have

  • Master's degree in engineering field
  • Knowledge of process monitoring systems (e.g., RJG, Kistler).
  • Six Sigma Green Belt or higher certification.
  • Strong leadership and project management skills, with a PMP certification preferred.
  • Core Competencies:
  • Analytical problem-solving and decision-making skills.
  • Excellent communication and interpersonal abilities.
  • Detail-oriented with a strong commitment to quality and compliance.

Skills

  • Please note the hours for this shift are Monday to Friday 1 PM-10 PM
  • Let's talk about Responsibilities
  • Research and integrate emerging technologies in LSR molding to improve efficiency and reduce waste.

Compensation

  • At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.

Benefits

  • Ensure all processes meet ISO 13485 and FDA regulations for medical device manufacturing.

Equal opportunity

  • Employer:
  • ResMed is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
  • We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world's best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance. Employees accrue fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.
  • Individual pay decisions are based on a variety of factors, such as the candidate's geographic work location, relevant qualifications, work experience, and skills.
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